Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV
NCT ID: NCT00130273
Last Updated: 2012-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
180 participants
INTERVENTIONAL
2005-07-31
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The treatment part of this study will last 12 months. Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count. Follow-up phone interviews will be conducted every year for 3 years after the end of treatment.
Study hypothesis: Managed problem solving will result in better adherence to highly active antiretroviral therapy (HAART) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Participants will receive managed problem solving for 12 months
Managed problem solving
Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
2
Participants will receive standard of care for 12 months
Standard care
Participants will receive standard of care for 12 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Managed problem solving
Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
Standard care
Participants will receive standard of care for 12 months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Infection likely to be susceptible to a specific treatment regimen
* Have access to a telephone
* Willing and able to comply with all study requirements
* Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
* On a treatment regimen for less than 2 weeks prior to study entry
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Gross
Associate Professor of Medicine and Epidemiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Gross, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gross R, Bellamy SL, Chapman J, Han X, O'Duor J, Palmer SC, Houts PS, Coyne JC, Strom BL. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013 Feb 25;173(4):300-6. doi: 10.1001/jamainternmed.2013.2152.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.